BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM

    MDR report key: 16680116 · Received April 5, 2023

    Report

    Report Number
    3005180920-2023-00209
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 6, 2023
    Report Date
    May 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817076
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6)2023. LOT 2213534: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2022. EXPIRATION DATE: 2027-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW.

    Additional Manufacturer Narrative · 0

    CORRECTION OF THE DESCRIPTION. IT WAS REPORTED THAT IN THE PREVIOUS REVISION FEMUR, TIBIA AND INSERT WERE REVISED. IN REALITY, ONLY THE FEMUR AND INSERT WERE REVISED. SO THE DESCRIPTION HAS BEEN CHANGED.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON THE (B)(6)2022. ON THE (B)(6)2023, THE PATIENT WAS REVISED BECAUSE OF CAPSULE TEAR, DISLOCATED PATELLA AND SUBSIDED FEMORAL STEM. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL AND TIBIAL COMPONENTS. PRESENTLY, ON THE (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON THE (B)(6) 2022. ON THE (B)(6) 2023, THE PATIENT WAS REVISED BECAUSE OF CAPSULE TEAR, DISLOCATED PATELLA AND SUBSIDED FEMORAL STEM. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL COMPONENTS AND THE INSERT. PRESENTLY, ON THE (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242209 GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0310SCF 2213534 07630030817076

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention